Summary of the Alliance webinar with Dr. Jacqueline O’Shaughnessy, Acting FDA Chief Scientist
On January 25, the Alliance for a Stronger FDA held its first webinar of 2022, hosting Acting FDA Chief Scientist Dr. Jacqueline O’Shaughnessy. The Office of the Chief Scientist (OCS) is a hub for scientific programs that support the Centers, as well as the overall FDA mission. The Chief Scientist oversees initiatives involving advancing regulatory science, technology transfer, scientific professional development, and scientific integrity. The Office also oversees the FDA’s Medical Countermeasures Initiative (MCMi).
During this informative webinar, Dr. O’Shaughnessy thanked the Alliance for its recognition of the importance of FDA and for its support of strong funding of the agency. She spoke about the importance of high-quality science in regulatory activities. OCS is unique in that it encourages scientific engagement within FDA and outside the agency.
Dr. O’Shaughnessy provided an overview of the broad range of activities within OCS. She identified the Office of Regulatory Science and Innovation, whose mission is to provide excellence and innovation in strategic leadership, collaboration, coordination, and infrastructure development so as to ensure FDA continues to have a strong regulatory science foundation; the Office of Counterterrorism and Emerging Threats, which deals with FDA-wide medical countermeasures; the Office of Laboratory Safety, which works on laboratory science, safety, and security best practices; the Office of Scientific Integrity; the Office of Scientific Professional Development, which offers education and training programs, and the National Center for Toxicological Research.
Dr. O’Shaughnessy offered several examples of the work done by OCS, including oversight of human subject research; FDA’s One Health Initiative; the Animal Welfare Council; Centers for Excellence research involving academic institutions; and the advancement of regulatory science developing new tools and standard approaches for the efficiency of FDA regulated products. She said that responsibilities have increased significantly.
Appreciating the Alliance’s focus on the budget, she said that OCS operates with a budget of $37.5 million before the contribution of other critical funds. She noted that the FY 2022 Budget Request includes an increase of $6.6 million to support the Office of Laboratory Safety. She also suggested the need to leverage the budget. Work is shaped by developments in science and regulatory health, using the response to COVID-19 as an example.
Dr. O’Shaughnessy also emphasized the need to ensure that there is sufficient personnel. Recruiting, hiring, and retention are all essential to OCS operations. They have had 107 FTEs over the past two years. They are strategic and targeted in identifying staffing requirements, and need to be forward-looking in nurturing, developing, and training with continuing education efforts. To develop this goal, they offer pretraining to pre- and post-doctoral professionals in natural sciences.
OCS effectively collaborates with other federal agencies through the use of MOUs.
In response to various questions, Dr. O’Shaughnessy said:
There needs to be a response to demand for new and more modern technology and to do so quickly. She spoke about the Technology Transfer Program, using science and patent law, keeping in step with industry, particularly with digital modernization efforts.
She elaborated on the additional $6.6 million funding request for the Office of Laboratory Safety and its cross-cutting work. The additional dollars are for work to increase efficiency, enhance safety, sustain the development of agency-wide standards and policies, as well as training.
With respect to the oversight of advisory committees, she said the purpose is to ensure the smooth conduct of the committees, making sure that the meetings comply with statutory and regulatory requirements.
With respect to assessing which changes in operations are useful and which ones may not be, she pointed to the Office of Regulatory Science and Innovation for leveraging scientific engagement and coordination. She suggested that a key accomplishment is the focus area on regulatory science to facilitate the development of innovative products.
With respect to Emergency Use Authorizations, she said there have been 400 EUAs covering more than 800 medical products and vaccines in response to the pandemic. Regular oversight is provided by the traditional center responsible for scientific review. OCS is responsible for coordination.
The Alliance is planning a full series of robust webinars for 2022; this was the first. Look to Friday Update for the announcement of upcoming events and be sure to register.
Editorial Note: The week’s Analysis and Commentary section was written by the Alliance’s Executive Director, Steven Grossman.